Niranjan Kanaki
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View article: Cross-Salt Extrapolation in the European Union: Regulatory, Scientific, and Strategic Considerations
Cross-Salt Extrapolation in the European Union: Regulatory, Scientific, and Strategic Considerations Open
Cross-salt extrapolation—the scientific and regulatory practice of bridging non-clinical or clinical data from one salt form of an active pharmaceutical ingredient (API) to another—has gained increasing relevance within the European Union …
View article: Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US
Comparative evaluation of Food for Special Dietary Use (FSDU) and Food for Special Medical Purpose (FSMP) product regulatory framework in India, EU and US Open
Nutraceuticals are naturally occurring compounds that is used globally due to its varied health benefits that extends beyond to basic nutrition. Various types of compounds are included in the umbrella term of nutraceuticals, including vita…
View article: Dossier submission in the UK after Brexit
Dossier submission in the UK after Brexit Open
The withdrawal of the United Kingdom (UK) from the European Union (EU), commonly known as Brexit, occurred on January 31, 2020, triggering a transition period until December 31, 2020, during which the UK and EU negotiated their future rela…
View article: Regulatory and Quality Compliance of Oncology Products – A Global perspective
Regulatory and Quality Compliance of Oncology Products – A Global perspective Open
The development and manufacturing of oncology products pose unique challenges in ensuring both regulatory compliance and high-quality standards. Oncology products, often complex biopharmaceuticals, play a critical role in cancer treatment,…
View article: OTC drug filing and review process in the US
OTC drug filing and review process in the US Open
The Over-the-Counter (OTC) Drug Monograph System in the United States (US) serves as a vital regulatory framework for non-prescription medications. Through the monograph review process there is a low regulatory burden for industry to marke…
View article: Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU)
Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU) Open
The market for biotechnology-derived medicinal products is evolving rapidly with the imminent entry of biosimilars. The development and approval of biosimilars represent a critical pathway to expanding access to biological therapies while …
View article: Overview of Post-approval Submissions Management in US, Europe and Canada
Overview of Post-approval Submissions Management in US, Europe and Canada Open
In today’s business era & competition in pharmaceutical industries, post-approval evaluation & cGMP compliance plays an important role. Regulatory approval is a critical milestone in the lifecycle of pharmaceuticals and medical devices, en…
View article: Effect of ethnomedicinal plants on osteoblast proliferation using cell line based assay method
Effect of ethnomedicinal plants on osteoblast proliferation using cell line based assay method Open
Osteoporosis reduced bone strength and it is responsible for bone fractures. Worldwide, approximately one in three women and one in five men over the age of 50 will suffer an osteoporotic fracture in their remaining lifetime. Since many de…
View article: Assessment of diurnal variation in Ocimum sanctum Linn. by gas chromatographic fingerprint analysis coupled with chemometric methods
Assessment of diurnal variation in Ocimum sanctum Linn. by gas chromatographic fingerprint analysis coupled with chemometric methods Open
Vast intra-specific variations, especially diurnal, geographical and seasonal, have been reported in the chemical composition of essential oils of Ocimum species. The study was conducted to assess diurnal variation in the chemical composit…
View article: Development of Simultaneous HPTLC Method for estimation of Boswellic acid, Curcumin and Diosgenin in Polyherbal Transdermal Gel
Development of Simultaneous HPTLC Method for estimation of Boswellic acid, Curcumin and Diosgenin in Polyherbal Transdermal Gel Open
Background: Boswellic acid, curcumin and diosgenin are important phytoconstituents present in Boswellia serrata, Curcuma longa and Trigonella foenum-graecum, respectively. Traditionally, these plants are used in the treatment of arthritis.…
View article: Geographical classification of Adhatoda vasica based on HPLC fingerprint analysis coupled with multivariate analysis
Geographical classification of Adhatoda vasica based on HPLC fingerprint analysis coupled with multivariate analysis Open
Adhatoda vasica (Nees) of family acanthaceae is a shrub growing throughout the Indian cape and is valued for having alkaloids with bronchodilation activity. Both seasonal and geographical variation is witnessed for the chemical constituent…